A PHASE 1, OPEN-LABEL, DOSE ESCALATION STUDY OF PF-04518600 AS A SINGLE AGENT AND IN COMBINATION WITH PF-05082566 IN PATIENTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC CARCINOMAS

Protocol: 
AAAQ8228
Phase: 
I

A PHASE 1, OPEN-LABEL, DOSE ESCALATION STUDY OF PF-04518600 AS A SINGLE AGENT AND IN COMBINATION WITH PF-05082566 IN PATIENTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC CARCINOMAS

The purpose of this research study is to learn about the effects of the study drugs, PF-04518600 and PF-05082566, and to: - Find out what side effects occur when PF-04518600 is given alone or in combination with PF-05082566, and how long they last, - Find the optimal dose of PF-04518600 alone or in combination with PF-05082566, for treating adult research subjects/participants with cancer. - Measure how much of PF-04518600 or PF-05082566 is in your blood after you take the study drug(s), - Find out if your body makes antibodies against PF-04518600 or PF-05082566, - Find out if PF-04518600 given alone or in combination with PF-05082566 changes how your immune system responds to cancer, - Find out if PF-04518600 given alone or in combination with PF-05082566 will be effective in shrinking tumors.

Are you Eligible? (Inclusion Criteria)

1)Must be at least 18 years of age.
2)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
3)Resolved acute effects of any prior therapy to baseline severity or Grade <=1
CTCAE except for AEs not constituting a safety risk by investigator judgement.
4)Serum or urine pregnancy test negative at screening and at the baseline visit
before the patient may receive the investigational product.
5)Male and female patients of childbearing potential and at risk for pregnancy
must agree to use two highly effective method(s) of contraception throughout.

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States